|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Hematology Advisor’s conference coverage.|
For patients with diffuse large B-cell lymphoma (DLBCL) in first complete remission (CR), maintenance therapy with rituximab may yield no survival advantage over observation after induction with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), according to research presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
The study was the second of 2 stages of a phase 3 trial (Netherlands Trial Register Identifier: NTR1014). The initial stage of the trial had tested outcomes with rituximab intensification during induction with R-CHOP and showed no benefit with early rituximab intensification. Patients achieving CR after the initial trial stage were randomly assigned into the second trial stage, during which rituximab was evaluated for maintenance.
In one treatment arm of the study, patients underwent maintenance with 375 mg/m2 intravenous rituximab administered at 8-week intervals for 24 months (199 patients). The other treatment arm underwent observation (199 patients). Disease-free survival (DFS) since randomization into the second trial stage was the primary endpoint of the study.
The study follow-up occurred at a median of 79.9 months. Rates of 5-year DFS were similar between the 2 groups: 79% with rituximab maintenance and 74% with observation (adjusted hazard ratio [aHR], 0.83; 95% CI, 0.57-1.19; P =.31).
Five-year overall survival rates were also similar between the groups, with rates of 85% for the rituximab maintenance arm and 83% for the observation arm. This difference was not statistically significant.
In the rituximab maintenance arm, 17% of patients showed grade 3 adverse events (AEs) and 6% showed grade 4 AEs. The most common AE was infection, with 6% of patients developing grade 3 infections. Grade 4 neutropenia occurred in 3% of patients and grade 3 neutropenia occurred in 1%.
For this study population, maintenance therapy with rituximab displayed no advantage compared with observation alone.
- Lugtenburg EJ, Brown P, van der Holt B, et al. Rituximab maintenance for patients with diffuse large B-cell lymphoma in first complete remission: Results from a randomized HOVON-Nordic Lymphoma Group phase III study. Oral presentation at: 2019 ASCO Annual Meeting; June 4, 2019; Chicago, IL. Abstract 7507.